A tracheostomy tube is a short curved tube inserted through a surgical hole in a patient's neck and held in place with a tracheostomy tie around the patient's neck. The purpose of a tracheostomy tube is to provide the patient with an airway or to provide the patient with an access that facilitates the suction of secretions from the airway.
Patients have tracheostomy tubes placed for numerous reasons. Once the reason that necessitated the placement of a tracheostomy tube has been resolved, the tracheostomy tube is normally removed. This procedure is known as decannulation. After the patient is decannulated, there remains a hole in the patient's neck which is known as a stoma. Once the patient is decannulated the stoma will usually close on its own in the majority of the patients. This normally occurs in two to three weeks. Surgical closure of the stoma is required for the patients whose stomas do not close on their own.
Currently, when a patient is decannulated, an occlusive or simply a gauze bandage type of arrangement is placed on the patient for days following decannulation. Once the patient leaves the hospital and in some cases even within the hospital such as from an Intensive Care Unit to a Regular Care Unit, the usual method of covering the stoma is to use the bandage. The patient is then instructed to cover the stoma with a finger when the patient needs to speak or cough.
This method of covering the stoma with the bandage, and using a finger to occlude the stoma in order to talk, suffers from a number of disadvantages. First, if the patient is a child, or a developmentally or physically disabled adult, he or she may not be able to occlude the stoma with a finger as needed. Second, in all patients, if the stoma is not covered in a somewhat airtight fashion, air passing in and out of the stoma when the patient attempts to talk, causes difficulty with or even makes it impossible for the patient to have the ability to speak. Third, when the patient coughs without covering the stoma, air is forced out of the stoma, and even normal breathing can cause air to pass in and out of the stoma if only covered by the bandage. This air movement through the stoma reduces the chance of the stoma closing on its own without surgery. Fourth, touching the stoma with the patient's fingers to talk or cough greatly increases the chances for infection of the patient's stoma and airway, and may lead to contamination and spreading of infection. Fifthly, in existing products, the pressure over the stoma is not constant and air leaks out during speaking and coughing, the patient thus loses their ability to cough effectively. There is also a risk of Atelectasis (the collapse or closure of alveoli), which can be a consequence of lack of post-expiratory pressure and may affect part or all of a lung resulting in hypoventilation with reduced or absent gas exchange. Atelectasis often correlates with the accumulation of mucus and it may lead to pneumonia in some cases.
Patients in intensive care units (ICU) suffering from critical illness or undergoing major surgery are provided with a tracheostomy tube (TT) if they are expected to require mechanical ventilation for more than about 7 days. A TT makes it easier to wean the patient off mechanical ventilation for a number of reasons. For example, the caregivers can minimize the sedation given to the patient as a TT does not provoke gag reflexes (versus an oral tube). Minimizing the administration of sedatives promotes circulation in the patient. Also, the patient can be active in his own care and mobilization, and awake patients can be participate in pulmonary physiotherapy.
When a TT is removed, the patient is robbed of an ability to provide a vital protection in his airway. The patient is no longer able to create an overpressure in their lungs and chest, which is necessary to clear their airways effectively from secretions/mucus. This is because of air leaking from the stoma. When the patient is weaned from mechanical ventilation they will be equipped with a speaking valve or cap on the tracheostomy tube that will enable them to create a positive pressure (Autopeep) in their chest. The Autopeep (peep is positive end expiratory pressure) is the natural counter-pressure that is created continuously by closing the vocal cords. It is typically a pressure of 5 cm H2O, and during a cough can even be >400 cm H2O in the chest.
This is important for a number of reasons, including:                the ability to create a voice with successful phonation,        to cough effectively and eliminate secretions,        make deep sighs to open lower parts of the lungs,        prevent atelectasis,        prevent infections—bronchitis and pneumonia, and        maintain sufficient ventilation for oxygen uptake and elimination of carbon dioxide.        
The positive pressure is created by a breath/inspiration followed by closing the vocal cords and a relaxed or forced expiration against the closed vocal cords.
With a capped TT the physician or caregiver can also check if the patient's upper airway is free and if they are doing the respiratory work sufficiently well without mechanical help.
When a TT is removed from a patient, they are placed back to a vulnerable situation because there will be an open artificial airway through the stoma, and the patient loses their Autopeep. The typical patient has been ill for weeks, their respiratory muscles are weakened/atrophic, and malnutrition and muscle atrophia are well known results from a long hospital stay.
Although the decannulated patient can breathe/expirate against their closed vocal cords, the maneuver will lack efficiency in the airways due to the opening (stoma) in the front of their neck (the vocal cords are above the tracheostoma).
This situation can be simulated by trying to cough against open vocal cords to feel the inefficiency of such a cough. The strength of the cough will be substantially reduced. The patient's condition may be complicated by weakened respiratory muscles (chest and diaphragm), which may be weakened as a result of mechanical ventilation. During controlled mechanical ventilation the patient's respiratory muscles are moved passively by the pressure from the ventilator/respirator. Any muscle will atrophy by inactivity and the degeneration of muscle tissue may be accelerated by sub-optimal nutrition during a hospital stay. Moreover, the patient will struggle with increased amounts of secretions in their airway due to the newly removed foreign body (TT) and irritated mucous membrane in the trachea wall after numerous suction procedures with catheters, and some patients will even suffer from pneumonia.
When a TT is removed (it is typically a decision by an anesthetist) the stoma/hole will be covered with a bandage. Some caregivers prefer to use an airtight occlusive dressing, which results in a continuous changing of bandages as it will loosen during coughs, talking or pulmonary physiotherapy due to increased pressure from the airway. Secretions from the airway (often infected) will contaminate the front side of the patient's neck. The patient will touch it in an attempt to tidy themselves up, and the majority of the patient group will not have the energy to go and wash their hands afterwards. Typically, the nurse will help the patient with cleaning if they are in the patient room. The nurse will normally try different types of occlusive dressings, and the frequent use and changing of these dressing can lead to excoriation.
Another drawback in relation using an occluding bandage is that secretions will collect and stagnate within the stoma channel, which impedes healing, worsen infection or risk of infection, and a constant flow of air through the stoma disturbs the tissue closing and healing.
Other caregivers acknowledge the above-mentioned challenge and prefer an absorbing non-airtight bandage such as cotton-gauze held in place with skin-gentle tape. This gives the advantage of having absorbing material in a bandage that may be held in place on the patient a bit longer than the airtight dressing as it allows for the passage of air. A disadvantage is that the patient loses their peep unless the bandage is held towards the neck manually. The situation is complicated by the fact that it is not possible to tighten a bandage around the neck as a stoma is located at the very lowest part of the neck.
Some hospitals practice a step-down unit for patients with tracheostomies, which has special skilled nurses and generally a higher staffing compared to normal wards. A general ward has a lower nurse to patient ratio and cannot offer the patient with a tracheostoma optimal help. Studies show that the discharge of a patient with a tracheostomy tube in situ to a ward is associated with increased mortality. The patient is dependent on their assigned nurse, their vigilance and time. The observation and care of a decannulated patient is a challenge as variations in measureable parameters may occur delayed for hours, days, or even weeks. A struggle may be hidden by an increase in inspiration time, respiration frequency, the use of secondary respiratory muscles. Medical notes may report that the patient seem more dyspnea or more labored in his breathing. It is a fact that complications are given more attention when the variation is numerically measureable.
Severe signs of insufficient breathing such as secretion stagnation and need of suction (via nose or mouth, which can be a painful and very unpleasant procedure for the patient), temperature increase, pneumonia, reduced oxygen uptake/reduced oxygen supply to organs, and accumulation of carbon dioxide are all challenges that the newly decannulated patients are facing. The respiratory insufficiency in some cases leads to an unplanned return to the intensive care unit. General deterioration is difficult to separate from the previous clinical picture.
There exists a need for improved treatment of a tracheostoma in a patient.